NCT06492798 Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients
| NCT ID | NCT06492798 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Changhai Hospital |
| Condition | Long COVID |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2023-09-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include: * whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients * whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients. Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted. Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that. Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.
Eligibility Criteria
Inclusion Criteria: * Meeting the diagnostic criteria for Long COVID according to WHO. * Main symptoms assessed based on CTCAE 5.0. * Symptoms evaluated for exclusion reasons of other diseases by relevant specialists. * No recent plans for pregnancy (negative pregnancy test within 72 hours for women of childbearing age prior to the start of the trial), and willing to use effective non-pharmaceutical contraceptive measures during the study. * Signed informed consent forms and agreements to participate in this clinical trial. Exclusion Criteria: * Active malignant tumors. * Active infections. * Abnormal liver or kidney function (ALT, AST \> 2 times the upper limit of normal; Cr \> 2 times the upper limit of normal). * Women who are pregnant, lactating, or planning to become pregnant during the trial. * Participated in other clinical trials within the last 3 months prior to screening. * Other reasons deemed inappropriate for participation by the investigator.
Contact & Investigator
Yuchao Dong, Doctor
STUDY DIRECTOR
Changhai Hospital
Frequently Asked Questions
Who can join the NCT06492798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Long COVID. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06492798 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06492798 currently recruiting?
Yes, NCT06492798 is actively recruiting participants. Contact the research team at dongyc1020@aliyun.com for enrollment information.
Where is the NCT06492798 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06492798 clinical trial?
NCT06492798 is sponsored by Changhai Hospital. The principal investigator is Yuchao Dong, Doctor at Changhai Hospital. The trial plans to enroll 76 participants.
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